The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Powerport Duo M.r.i. Implanted Port With 9.5 Fr. Dual Lumen Chronoflex Polyurethane Catheter.
| Device ID | K090512 |
| 510k Number | K090512 |
| Device Name: | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Angela M Brady |
| Correspondent | Angela M Brady C.R. BARD, INC. 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2009-03-27 |
| Summary: | summary |